Sitemap Pages About Contact us Copyright Policy and Terms of Use Disclaimer Guidelines Method of Analysis (MOA) Microbiology Packaging Materials Privacy Policy Quality Assurance Quality Control Sitemap Validation Posts by category Category: guideline Understanding Pharmaceutical Excipients Bulk Density vs Tap Density 21 CFR Guidelines Explained Major Regulatory Agencies in the Pharmaceutical Industry and Their Roles Types of Chromatography in Pharmaceutical Analysis Difference Between Assay, Purity, and Potency in Pharmaceuticals Why Are Three Batches Used for Process Validation in Pharmaceuticals? OOS vs OOT in Pharmaceuticals: Key Differences, Examples, and Actions Types of Calibration Weights in the Pharmaceutical Industry Category: Guidelines SOP vs STP Swab Sampling in Pharmaceuticals LOD vs Moisture Content Deviation vs Incident The Basics of Quality Management Systems (QMS) 💊 Pharmaceutical Document Control – GMP Essentials What Is Quality Control TAT? Meaning, Importance & How to Improve It Site Master File – EU GMP 21 CFR Part 211-cGMP Containers-Glass Self Inspection – EU GMP Complaints and Product Recalls – EU GMP Outsourced Activities – EU GMP Production – EU GMP Documentation – EU GMP Premises and Equipment – EU GMP Personnel – EU GMP Pharmaceutical Quality System – EU GMP SCHEDULE M-II SCHEDUE M-I SCHEDULE M – GMP – PART 7 (API-BULK DRUGS) SCHEDULE M – GMP – PART 6 (METERED-DOSE-INHALERS) SCHEDULE M – GMP – PART 5 (TOPICAL PRODUCTS) SCHEDULE M – GMP – PART 4 (ORAL LIQUIDS) SCHEDULE M – GMP – PART 3 (PARENTERAL PREPARATIONS) SCHEDULE M – GMP – PART 2 (OSD) Data Integrity – ALCOA+ What is CAPA – Corrective and preventative action ICH Guidelines Category: Incident Quality Control Department Incidents – HPLC Instrument Malfunction Regulatory & Compliance Incidents-Non-compliance observed during self-inspection or regulatory audits Warehouse & Logistics Incidents-Wrong material issuance (mix-up in API/excipient/packing material) Safety & EHS (Environment, Health & Safety) Incidents-Spillage of raw materials, solvents, or intermediates Quality & GMP Incidents-Packaging Error (wrong label / misprinted batch number / missing leaflet) Quality & GMP Incidents-Deviation from Approved SOPs Production & Process Incidents-Power Failure / Sudden Line Stoppage Production & Process Incidents-Equipment breakdown or malfunction Category: Method of Analysis Spectral Transmission for Colored Glass Containers Arsenic Test For Glass Container – USP Surface Etching Test – USP Surface Glass Test Limit Tests Category: Microbiology Microbiological Control Tests Aseptic Processing – Sterile Pharmaceutical SOP for Entry and Exit Procedure in Microbiology Lab Preparation and Destruction of Media for Microbiological Analysis – SOP Subculturing of Master and Maintenance of Microbiological Cultures – SOP Receiving and Maintaining the Stock of Media – SOP Qualification of Autoclave – SOP Microbiological Qualification of Area – SOP Microbial Limit Test for Raw Materials – SOP Category: Packaging Material Bursting Strength Tester SOP for Bursting Strength Tester Packaging Material Vendor Audit Checklist Poly laminated aluminium tagger – Packaging material standard test procedure HDPE Jar – Packaging material standard test procedure Cap for HDPE Jar – Packaging material standard test procedure Poly bag – Packaging material standard test procedure Silica gel bag – Packaging material standard test procedure Poly laminated foil (printed) – Packaging material standard test procedure Cold forming aluminium foil – Packaging material standard test procedure Cold forming aluminium foil – Packaging material standard test procedure Cap for glass bottle – Packaging material standard test procedure Glass Bottle – Packaging material standard test procedure Sticker label – Packaging material standard test procedure Leaflet – Packaging material standard test procedure LDPE BAGS – Packaging material standard test procedure BOPP TAPE– Packaging material standard test procedure Strapping Roll – Packaging material standard test procedure Shrink– Packaging material standard test procedure PVC Film – Packaging material standard test procedure Aluminium Foil (Printed) – Packaging material standard test procedure Corrugated Box– Packaging material standard test procedure Catch Cover– Packaging material standard test procedure Cartons – Packaging material standard test procedure Category: Quality Assurance SCHEDULE M – GMP – PART 1 Self Inspection Checklist Rinse and Swab Sampling From Equipment’s Product Contact Surface SOP Usage Entry on Log Books SOP Handling of Hazardous Chemicals SOP Allocating identification number to instrument / equipment / utility Specimen Signature SOP Preparation of User Requirement Specification (URS) SOP Handling of Out Of Trend (OOT) SOP Out of Specification Flow Chart of Investigation for different Phases Flowchart for Quality Risk Management and Quality Risk Management Process Quality Risk Management SOP Reconciliation During Batch Manufacturing and Batch Packing SOP Temperature Mapping SOP Management of Batch Manufacturing Record and Batch Packing Record SOP Calibration By External Agency SOP Sampling of Intermediate and Finished Product SOP Stability Studies SOP Handling of Online Rejection SOP Corrective Action and Preventive Action (CAPA) SOP Failure Investigation SOP Incident Management SOP In Process Quality Assurance (IPQA) SOP Annual Product Quality Review (APQR) SOP Line Clearance SOP Cleaning Validation SOP Approval of Finished Goods SOP Qualification of Equipment / Instrument / Utilities SOP Out of Specification SOP Handling of Returned Goods SOP Assigning Manufacturing and Expiry Date SOP Allocation of Product Batch Number SOP Change Control Flow Chart Handling of Market Complaints SOP Product Recall Flow Chart Product Recall SOP Self Inspection SOP Vendor Qualification SOP Change Control SOP Training SOP Handling of Deviation – SOP Documentation – SOP Preparation of Site Master File – SOP Preparation, review, approval, distribution control, revision, retrieval and destruction of standard operating procedure – SOP (SOP for SOP) Category: Quality control Glass Grains Test – USP STANDARD SOLUTIONS FOR LIMIT TESTS SCHEDULE L-1 (GLP) Calibration of Gas Chromatography SOP Analyst Qualification Criteria Disintegration Test Karl Fischer Titration Residue on ignition / Sulfated ash Loss on drying Dissolution Test SOP for Hardness Tester Out of Specification (OOS) Daily Maintenance and Common problems in HPLC INFRARED ABSORPTION SPECTROSCOPY Tap Density Tester SOP Quality Control – Principle, General information HPLC Basics- Principle and Scope Good Laboratory Practice – GLP SOP for Operation and Calibration of Total Organic Carbon analyzer. (TOC) Rounding off Analytical Results SOP Analytical Method Transfer SOP (AMT) Electrolab Friability Test Apparatus SOP Electrolab Disintegration Test Apparatus SOP SOP of Desiccator Operation of Viscometer SOP Operation of High Performance Liquid Chromatography (HPLC) SOP Operation of Dissolution Test Apparatus SOP Testing and Release of In process samples, Semi Finished Products and Finished Product Sampling, Testing and Release of Water and Pure Steam Operation and Calibration of Disintegration Test Apparatus SOP Good Laboratory Practice SOP Operation of Micrometer Screw Gauge SOP Operation of Reverse Laminar Air Flow Unit SOP Operation and Calibration of Hot Air Oven SOP Operation and Calibration Of UV Cabinet SOP Operation and Calibration of Polarimeter SOP Operation and Calibration of Refractometer SOP (Make-Rajdhani) Operation and Calibration of Friability Test Apparatus SOP Analyst Qualification SOP Adjustment of Chromatographic Conditions as per BP / USP (for HPLC) Good Chromatographic Practices SOP Audit Trail SOP Investigating and Handling of Out Of Trend (OOT) Test Results SOP Investigating and Handling Of Out Of Specification (OOS) Test Results SOP Handling of Out Of Calibration (OOC) SOP Handling of The Spillage SOP Cleaning of Glassware in Laboratory SOP Calibration of Dissolution Test Apparatus SOP Operation and Calibration of pH Meter/ Conductivity Meter Operation of Ultrasonic Cleaner SOP Cleaning and Operation of COD Digester SOP Operation of Digital Micrometer SOP Operation and Calibration of Karl Fischer Titrator SOP Calibration of Fourier Transform Infra-red Spectrophotometer (FTIR) SOP Calibration of High Performance Liquid Chromatography (HPLC) SOP Calibration of Ultraviolet Visible Spectrophotometer SOP Calibration of Analytical Balance SOP User Requirement Specification Example – Instrument Abbreviations SOP Inventory of Reagents/Indicators and Other Items SOP Calibration of Glass Apparatus SOP Analytical Method Validation SOP Shelf life of Volumetric Solutions – SOP Preparation, Standardisation and Storage of Laboratory Solutions – SOP Contract Laboratory Approval and Contract Analysis – SOP HPLC Column Management – SOP Preparation and Handling of Working Standards – SOP Procurement and Handling of Reference Standards – SOP Disposal of Laboratory Waste – SOP Handling of Raw Material Under Retest Due – SOP Analysis of Raw Materials – SOP Analytical Specifications, Standard Test Procedures and Worksheets – SOP Control Sample Management-SOP Entry And Exit from Quality Control Department-SOP Sampling of Raw material and cleaning of sampling aids-SOP Opening and Closing of the Quality Control Department – SOP Category: SOP Water Sampling Procedure for Microbiological analysis Purity Testing of Microbiological Cultures – SOP Microbial Limit Test for Finished Products – SOP Microbial Limit Test For Primary Packaging Materials – SOP Microbial Evaluation By Swab Method – SOP Cleaning and operation of Laminar Air Flow (LAF)-SOP Cleaning and operation of colony counter-SOP Cleaning and operation of light microscope-SOP Cleaning and operation of zone reader-SOP Growth Promotion Test-SOP Cleaning and Operation of Refrigerators-SOP Cleaning and Operation of Incubators-SOP Receiving, Issuance and Verification of Biological Indicators-SOP Destruction of Microbial Waste-SOP Destruction and Disposal of Expired Media-SOP Cleaning In Microbiology Section-SOP Sampling, Testing and Approval/Rejection of Packaging Material – SOP Validation Master Plan – SOP Checking personnel hygiene by dab test method-SOP Category: Uncategorized Buffers in HPLC: Why Are Buffers Essential in HPLC Analysis? Different Grades of Water in the Pharmaceutical and Analytical Industry Category: Validation Area Qualification SOP Process Validation SOP Share this: Click to share on WhatsApp (Opens in new window) WhatsApp Click to share on Facebook (Opens in new window) Facebook Click to share on LinkedIn (Opens in new window) LinkedIn Click to share on X (Opens in new window) X Click to share on Telegram (Opens in new window) Telegram Like this:Like Loading...
